NCT01994772

Brief Summary

Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock. There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
584

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 26, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2018

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

4.2 years

First QC Date

November 7, 2013

Last Update Submit

January 14, 2019

Conditions

Cardiac Arrest

Keywords

Therapeutic hypothermiaTargeted controlled temperatureCardiac arrestNon shockable rhythmsuccessful resuscitation

Outcome Measures

Primary Outcomes (1)

  • Neurological outcome assessed with Cerebral Performance Category scale

    Day 90

Secondary Outcomes (20)

  • Intensive Care Unit Mortality

    Discharge from Intensive Care Unit, an expected average of 7 days

  • Hospital Mortality

    Discharge from hospital, an expected average of 2 weeks

  • Mortality at day 90

    Day 90

  • Quality of life Score

    Day 90

  • Life autonomy

    Day 90

  • +15 more secondary outcomes

Study Arms (2)

Targeted controlled temperature between 32.5 and 33.5°C

ACTIVE COMPARATOR

Patients will be placed in targeted temperature control between 32.5 and 33.5 ° C for 24 hours and then slowly rewarmed for targeted temperature control between 36.5 and 37.5 ° C for 24 hours.

Procedure: Targeted controlled temperature between 32.5 and 33.5°CProcedure: Targeted controlled temperature between 36.5 and 37.5°C

Targeted controlled temperature between 36.5 and 37.5°C

PLACEBO COMPARATOR

Patients will be placed in targeted temperature control between 36.5 and 37.5 ° C for 48 hours.

Procedure: Targeted controlled temperature between 36.5 and 37.5°C

Interventions

Targeted controlled temperature between 32.5 and 33.5°CPROCEDURE

Therapeutic hypothermia ie targeted controlled temperature between 32.5° and 33.5°C will be induced in the active group. Usual method of controlled temperature will be use in ICU: internal active method or external active method.

Also known as: Therapeutic hypothermia, Induce hypothermia
Targeted controlled temperature between 32.5 and 33.5°C
Targeted controlled temperature between 36.5 and 37.5°CPROCEDURE

Temperature was maintain between 36.5° and 37.5°C in the control group. In case of temperature superior to 37.5°C or inferior to 36.5°C, a pharmaceutical treatment and/or active cooling or warming was introduce to maintain temperature between the range of 36.5 - 37.5°C.

Also known as: Normothermia
Targeted controlled temperature between 32.5 and 33.5°CTargeted controlled temperature between 36.5 and 37.5°C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac arrest in non shockable rhythm
  • Glasgow score ≤ 8

You may not qualify if:

  • No flow \> 10 min
  • Low flow \> 60 min
  • Major hemodynamic instability
  • Cirrhosis Child C
  • Age \< 18 years
  • Pregnant women
  • Patient with no liberty
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Medical Intensive Care Unit

Angers, France

Location

Medical Surgical Intensive Care Unit

Angoulême, France

Location

Medical Intensive Care Unit

Annecy, 74374, France

Location

Medical Surgical Intensive Care Unit

Argenteuil, France

Location

Medical Intensive Care Unit

Clermont-Ferrand, 63003, France

Location

Medical Intensive Care Unit

Dijon, France

Location

Medical Surgical Intensive Care Unit

La Roche-sur-Yon, France

Location

Medical Surgical Intensive Care Unit

Le Mans, France

Location

Medical Surgical Intensive Care Unit

Lens, France

Location

Medical Intensive Care Unit

Lille, 59037, France

Location

Medical Surgical Intensive Care Unit

Limoges, France

Location

Medical Surgical Intensive Care Unit

Lorient, 56322, France

Location

Medical Surgical Intensive Care Unit

Montauban, France

Location

Medical Intensive Care Unit

Nantes, France

Location

Medical Intensive Care Unit

Orléans, France

Location

Cochin University Hospital Center

Paris, France

Location

Medical Intensive Care Unit

Poitiers, France

Location

Medical Surgical Intensive Care Unit

Roanne, 42300, France

Location

Medical Surgical Intensive Care Unit

Rodez, 12000, France

Location

Medical Surgical Intensive Care Unit

Saint-Brieuc, France

Location

Medical Surgical Intensive Care Unit

Saint-Nazaire, France

Location

Medical Surgical Intensive Care Unit

St-Malo, 35400, France

Location

Medical Intensive Care Unit

Strasbourg, France

Location

Medical Intensive Care Unit

Tours, France

Location

Medical Surgical Intensive Care Unit

Versailles, France

Location

CHU Pointe à Pitre

Pointe-à-Pitre, 97120, Guadeloupe

Location

Related Publications (4)

  • Lascarrou JB, Ermel C, Cariou A, Laitio T, Kirkegaard H, Soreide E, Grejs AM, Reinikainen M, Colin G, Taccone FS, Le Gouge A, Skrifvars MB. Dysnatremia at ICU admission and functional outcome of cardiac arrest: insights from four randomised controlled trials. Crit Care. 2023 Dec 1;27(1):472. doi: 10.1186/s13054-023-04715-z.

    PMID: 38041177DERIVED

  • Ziriat I, Le Thuaut A, Colin G, Merdji H, Grillet G, Girardie P, Souweine B, Dequin PF, Boulain T, Frat JP, Asfar P, Francois B, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Massart N, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Reignier J, Cariou A, Lascarrou JB. Outcomes of mild-to-moderate postresuscitation shock after non-shockable cardiac arrest and association with temperature management: a post hoc analysis of HYPERION trial data. Ann Intensive Care. 2022 Oct 17;12(1):96. doi: 10.1186/s13613-022-01071-z.

    PMID: 36251223DERIVED

  • Lascarrou JB, Merdji H, Le Gouge A, Colin G, Grillet G, Girardie P, Coupez E, Dequin PF, Cariou A, Boulain T, Brule N, Frat JP, Asfar P, Pichon N, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Letheulle J, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Giraudeau B, Reignier J; CRICS-TRIGGERSEP Group. Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm. N Engl J Med. 2019 Dec 12;381(24):2327-2337. doi: 10.1056/NEJMoa1906661. Epub 2019 Oct 2.

    PMID: 31577396DERIVED

  • Lascarrou JB, Meziani F, Le Gouge A, Boulain T, Bousser J, Belliard G, Asfar P, Frat JP, Dequin PF, Gouello JP, Delahaye A, Hssain AA, Chakarian JC, Pichon N, Desachy A, Bellec F, Thevenin D, Quenot JP, Sirodot M, Labadie F, Plantefeve G, Vivier D, Girardie P, Giraudeau B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group and HYPERION Study Group. Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial. Scand J Trauma Resusc Emerg Med. 2015 Mar 7;23:26. doi: 10.1186/s13049-015-0103-5.

    PMID: 25882712DERIVED

Related Links

MeSH Terms

Conditions

Heart Arrest

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Officials

  • Jean Baptiste Lascarrou, MD

    Nantes University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 26, 2013

Study Start

January 26, 2014

Primary Completion

April 9, 2018

Study Completion

April 9, 2018

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

GU(1)FR(25)